MAUDE Adverse Event Report: INFUSION DEVICES - UNKOWN

Lot Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that she was hospitalized due to high blood glucose and diabetic ketoacidosis because of infusion set malfunction.Her blood glucose level was 350 mg/dl and the cause of hospitalization as per the health care professional is diabetic ketoacidosis.She stated that it happened twice and on her second visit, she was transferred later to the intensive care unit and ended up staying at night and several nights.She was given intravenous fluids and insulin for three days.Reportedly, her hospital visits were 12 hours apart.No further information available.

• Brand Name: INFUSION DEVICES - UNKOWN
• Type of Device: INFUSION DEVICES - UNKOWN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8563442
• MDR Text Key: 143530021
• Report Number: 3003442380-2019-01399
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/11/2018
• Type of Device Usage: N
• Patient Sequence Number: 1